PsoriasisPhase 1CsA/MetNCT07375654
Combined Use of Cyclosporine and Metformin in Treatment of Psoriasis vs Cyclosporine Alone
A Phase 1 study testing Cyclosporin (CSA) and Metformin (500 mg Twice a day) in people with Psoriasis, run by Cairo University at 1 site in Egypt.
Trial summary
This study is a comparative clinical study evaluating the efficacy of combined therapy using cyclosporine and metformin versus cyclosporine alone in the treatment of psoriasis. Psoriasis is a chronic inflammatory skin disease that often requires systemic therapy in moderate to severe cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Cyclosporin (CSA) and Metformin (500 mg Twice a day)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Dec 2024to 4 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old
- Patients of both genders
- Patients clinically diagnosed as moderate to severe psoriasis candidate for systemic treatment with Psoriasis Area Severity Index (PASI >10), Body Surface Area (BSA>10), Dermatology Life Quality Index (DLQI>10).(Laura Salgado-Boquete et al., 2021).
- Patients with new active lesions and also patient with chronic lesions (with periods of remission and exacerbation)
Who cannot join
- Erythrodermic and pustular psoriasis.
- Patients with systemic illness ( renal, hepatic and uncontrolled hypertension ).
- Pregnant and lactating females.
- Patients receiving systemic treatment relevant to psoriasis within 3 months before enrollment into the study or topical treatment relevant to psoriasis within 1 month before.
- Patients with other dermatological conditions.
- Patients with high uric acid level .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study on the Efficacy of The Combined Use of Cyclosporine and Metformin in the Treatment of Psoriasis vs Cyclosporine Alone
This study is a comparative clinical study evaluating the efficacy of combined therapy using cyclosporine and metformin versus cyclosporine alone in the treatment of psoriasis. Psoriasis is a chronic inflammatory skin disease that often requires systemic therapy in moderate to severe cases. Cyclosporine is an effective immunosuppressive agent; however, its long-term use is limited by potential adverse effects.
Metformin, a commonly used antidiabetic drug, has shown anti-inflammatory and immunomodulatory properties, which may enhance treatment outcomes in psoriasis. This study aims to assess whether adding metformin to cyclosporine improves clinical response compared to cyclosporine monotherapy.
Read the detailed description
Psoriasis is a chronic, immune-mediated inflammatory skin disease characterized by erythematous, scaly plaques and a relapsing course. It has a significant negative impact on patients' quality of life and is frequently associated with metabolic comorbidities, including insulin resistance and obesity. Management of moderate to severe psoriasis often requires systemic therapy to achieve adequate disease control.
Cyclosporine is a well-established systemic immunosuppressive drug used in the treatment of moderate to severe psoriasis due to its rapid onset of action and effectiveness in reducing disease severity. Its mechanism involves inhibition of T-cell activation and cytokine production. However, long-term use of cyclosporine is limited by potential adverse effects, particularly nephrotoxicity, hypertension, and metabolic disturbances. Therefore, strategies to enhance its efficacy while potentially allowing dose reduction are of clinical importance.
Metformin is an oral hypoglycemic agent widely used in the management of type 2 diabetes mellitus. Beyond its glucose-lowering effect, metformin has demonstrated anti-inflammatory, immunomodulatory, and antiproliferative properties. Recent evidence suggests that metformin may play a beneficial role in inflammatory and immune-mediated diseases, including psoriasis, through modulation of inflammatory cytokines and improvement of insulin resistance, which is commonly observed in psoriatic patients.
This study is designed as a comparative clinical study to evaluate the efficacy of combined therapy using cyclosporine and metformin versus cyclosporine monotherapy in the treatment of psoriasis. The primary objective is to assess whether the addition of metformin enhances the clinical response compared to cyclosporine alone. Treatment efficacy will be evaluated using standardized clinical assessment tools for psoriasis severity, along with monitoring of treatment safety and tolerability.
- Conditions
- Psoriasis
- Being tested
- Cyclosporin (CSA), Metformin (500 mg Twice a day)
- Keywords
- psoriasis, cyclosporin, metformin
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporin (CSA)Drug
Cyclosporine (dose 3 mg/kg),orally twice per day for 3 months
Metformin (500 mg Twice a day)Drug
Metformin (500 mg twice daily),orally for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporin (CSA) | Active comparator | Group A: (16) patients will receive Cyclosporine (dose 3 mg/kg),orally twice per day for 3months Receives: Drug: Cyclosporin (CSA) |
| Cyclosporin plus Metformin | Active comparator | Group B: (16) patients will receive Cyclosporine(3mg/kg/day), orally and Metformin (500 mg twice daily) ,orally for 3 months Receives: Drug: Cyclosporin (CSA); Drug: Metformin (500 mg Twice a day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure 1 Change in Psoriasis Area and Severity Index (PASI)
Comparison of PASI scores before and after treatment within each group and between both treatment groups.
Unit of Measure:
PASI score
Scale:
0-72 (higher scores indicate more severe psoriasis)
Measured: Baseline (Pretreatment) ,Post-treatment(At 3 months),At 6 months
Primary Outcome Measure 2 Change in Body Surface Area (BSA)
Comparison of the percentage of body surface area affected by psoriasis before and after treatment within each group and between both treatment groups.
Unit of Measure:
Percentage of body surface area (%)
Scale:
0-100% (higher percentages indicate greater skin involvement)
Measured: Baseline (pretreatment), 3 months, and 6 months post-treatment
Primary Outcome Measure 3 Change in Dermatology Life Quality Index (DLQI)
Comparison of DLQI scores before and after treatment within each group and between both treatment groups.
Unit of Measure:
DLQI score
Scale:
0-30 (higher scores indicate greater impairment of quality of life)
Measured: Baseline (pretreatment), 3 months, and 6 months post-treatment
Secondary outcomes (1)
Patient satisfaction .
Patients' Global Satisfaction Scale ranging from -1 to 3. Patient satisfaction is graded as excellent (3), moderately satisfied (2), poorly satisfied (1), not satisfied (0), or condition worsened (-1), with higher scores indicating greater patient satisfaction and better clinical outcome.
Measured: Post treatment(AT 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start19 Dec 2024
- Primary completion4 Oct 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Patients will be divided randomly (by simple randomization) into 2 equal groups: Group A: (16) patients will receive Cyclosporine (dose 3 mg/kg). And group B: (16) patients will receive Cyclosporine and Metformin (500 mg twice daily). * The instruction to the both groups will be identical and they will receive the treatment for a total of 3 months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohamed Fahim, Cairo University
- Investigators
- Marwa Salah El-Mesidy, Assistant Professor, Principal investigator, Cairo UniversityAya Mohamed Fahim, Assistant Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375654
- Sponsor's protocol ID
- MS-308-2024
- Acronym
- CsA/Met
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Efficacy of The Combined Use of Cyclosporine and Metformin in the Treatment of Psoriasis vs Cyclosporine Alone
- ClinicalTrials.gov ID
- NCT07375654
- Acronym / sponsor ID
- CsA/Met / MS-308-2024
- Conditions
- Psoriasis
- Keywords
- psoriasis, cyclosporin, metformin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 4 Oct 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a comparative clinical study evaluating the efficacy of combined therapy using cyclosporine and metformin versus cyclosporine alone in the treatment of psoriasis. Psoriasis is a chronic inflammatory skin disease that often requires systemic therapy in moderate to severe cases. Cyclosporine is an effective immunosuppressive agent; however, its long-term use is limited by potential adverse effects.
Metformin, a commonly used antidiabetic drug, has shown anti-inflammatory and immunomodulatory properties, which may enhance treatment outcomes in psoriasis. This study aims to assess whether adding metformin to cyclosporine improves clinical response compared to cyclosporine monotherapy.
Detailed description
Psoriasis is a chronic, immune-mediated inflammatory skin disease characterized by erythematous, scaly plaques and a relapsing course. It has a significant negative impact on patients' quality of life and is frequently associated with metabolic comorbidities, including insulin resistance and obesity. Management of moderate to severe psoriasis often requires systemic therapy to achieve adequate disease control.
Cyclosporine is a well-established systemic immunosuppressive drug used in the treatment of moderate to severe psoriasis due to its rapid onset of action and effectiveness in reducing disease severity. Its mechanism involves inhibition of T-cell activation and cytokine production. However, long-term use of cyclosporine is limited by potential adverse effects, particularly nephrotoxicity, hypertension, and metabolic disturbances. Therefore, strategies to enhance its efficacy while potentially allowing dose reduction are of clinical importance.
Metformin is an oral hypoglycemic agent widely used in the management of type 2 diabetes mellitus. Beyond its glucose-lowering effect, metformin has demonstrated anti-inflammatory, immunomodulatory, and antiproliferative properties. Recent evidence suggests that metformin may play a beneficial role in inflammatory and immune-mediated diseases, including psoriasis, through modulation of inflammatory cytokines and improvement of insulin resistance, which is commonly observed in psoriatic patients.
This study is designed as a comparative clinical study to evaluate the efficacy of combined therapy using cyclosporine and metformin versus cyclosporine monotherapy in the treatment of psoriasis. The primary objective is to assess whether the addition of metformin enhances the clinical response compared to cyclosporine alone. Treatment efficacy will be evaluated using standardized clinical assessment tools for psoriasis severity, along with monitoring of treatment safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- * Patients will be divided randomly (by simple randomization) into 2 equal groups: Group A: (16) patients will receive Cyclosporine (dose 3 mg/kg). And group B: (16) patients will receive Cyclosporine and Metformin (500 mg twice daily). * The instruction to the both groups will be identical and they will receive the treatment for a total of 3 months.
| Arm | Type | Receives |
|---|---|---|
| Cyclosporin (CSA) | Active comparator | Drug: Cyclosporin (CSA)Group A: (16) patients will receive Cyclosporine (dose 3 mg/kg),orally twice per day for 3months |
| Cyclosporin plus Metformin | Active comparator | Drug: Cyclosporin (CSA), Drug: Metformin (500 mg Twice a day)Group B: (16) patients will receive Cyclosporine(3mg/kg/day), orally and Metformin (500 mg twice daily) ,orally for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥ 18 years old
- Patients of both genders
- Patients clinically diagnosed as moderate to severe psoriasis candidate for systemic treatment with Psoriasis Area Severity Index (PASI >10), Body Surface Area (BSA>10), Dermatology Life Quality Index (DLQI>10).(Laura Salgado-Boquete et al., 2021).
- Patients with new active lesions and also patient with chronic lesions (with periods of remission and exacerbation)
Key exclusion criteria (6 listed)
- Erythrodermic and pustular psoriasis.
- Patients with systemic illness ( renal, hepatic and uncontrolled hypertension ).
- Pregnant and lactating females.
- Patients receiving systemic treatment relevant to psoriasis within 3 months before enrollment into the study or topical treatment relevant to psoriasis within 1 month before.
- Patients with other dermatological conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporin (CSA)Cyclosporine (dose 3 mg/kg),orally twice per day for 3 months | Drug | Cyclosporin (CSA), Cyclosporin plus Metformin |
| Metformin (500 mg Twice a day)Metformin (500 mg twice daily),orally for 3 months | Drug | Cyclosporin plus Metformin |
Primary outcome
Primary Outcome Measure 1 Change in Psoriasis Area and Severity Index (PASI)
Time frame: Baseline (Pretreatment) ,Post-treatment(At 3 months),At 6 months
Comparison of PASI scores before and after treatment within each group and between both treatment groups. Unit of Measure: PASI score Scale: 0-72 (higher scores indicate more severe psoriasis)
Primary Outcome Measure 2 Change in Body Surface Area (BSA)
Time frame: Baseline (pretreatment), 3 months, and 6 months post-treatment
Comparison of the percentage of body surface area affected by psoriasis before and after treatment within each group and between both treatment groups. Unit of Measure: Percentage of body surface area (%) Scale: 0-100% (higher percentages indicate greater skin involvement)
Primary Outcome Measure 3 Change in Dermatology Life Quality Index (DLQI)
Time frame: Baseline (pretreatment), 3 months, and 6 months post-treatment
Comparison of DLQI scores before and after treatment within each group and between both treatment groups. Unit of Measure: DLQI score Scale: 0-30 (higher scores indicate greater impairment of quality of life)
1 secondary outcome
Patient satisfaction .
Time frame: Post treatment(AT 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Salah El-Mesidy, Assistant Professor principal investigator
Cairo University
Aya Mohamed Fahim, Assistant Professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclosporin (CSA) and Metformin (500 mg Twice a day) in people with Psoriasis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure 1 Change in Psoriasis Area and Severity Index (PASI) (time frame: Baseline (Pretreatment) ,Post-treatment(At 3 months),At 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.